MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number 1016002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2012.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.

Manufacturer Narrative

A review of the device history record for strattice lot s11080 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.A relationship between the strattice and this event could not be conclusively determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

On 20/feb/2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent an ¿umbilical¿ hernia surgery and was implanted with strattice device on (b)(6) 2012.The patient underwent a ¿chronically incarcerated incisional hernia with fat.Small 2cm defect repaired primarily due to presence of purlence [sic] around the prior mesh.Portion of mesh that was not well incorporated excised¿ on (b)(6) 2021.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, infection, unable to lift more than 10lbs, anxiety about not being able to work.¿ the form lists the condition that was treated was ¿pain¿ with approximate dates of treatment between 2018 to present.The patient also received treatment for ¿recurrence, pain, infection, omenectomy¿ in (b)(6) 2021.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18361022
• MDR Text Key: 330932820
• Report Number: 1000306051-2023-10023
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 1016002
• Device Lot Number: S11080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male